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In November 2017, the pharma industry was granted an extension of the Drug Supply Chain Security Act (DSCSA) enforcement date to November 2018. Regulators told the market that they would not actively enforce the new serialization requirements until this date.

Thierry Protas, Global Pharma Director at Videojet Technologies, looks at the importance of the Drug Supply Chain Security Act (DSCSA) legislation, the looming 2018 cut off point for compliance, and how coding and marking is a key consideration.

Standfirst:There is growing awareness of the valuable role that diagnostics can play, both in the early identification and treatment of dangerous or infectious diseases as well as genetic disorders.

Compliance is a serious issue for India’s pharmaceutical manufacturers, distributors, and retailers; due to the complicated nature of the pharmaceutical supply chain. Serialization requires pharmaceutical manufacturers to invest in new technology and adapt their current processes and systems.

What is a biosimilar?
Whereas generic drugs are identical copycats of small-molecule chemical products, biosimilars are only similar to biologic products; innately more complex than chemical products, biologics are large-molecule, organic drugs, subject to natural variability and vulnerability due to climate changes during the manufacturing process, and as such, it is impossible to produce an exact replica of a biologic—hence the adoption of the nomenclature, “biosimilar.”

Every day, the United States loses 116 lives to the opioid epidemic.(1) Pharmacists are asking what can be done to combat the opioid epidemic and treat pain effectively.

News & Press Releases

With 80 years of experience in water treatment and purification, the specialty chemicals company LANXESS with its Liquid Purification Technologies business unit (LPT), has a solid basis to appear at this year’s IFAT.

LANXESS India Private Limited, the leading specialty chemicals company has been acknowledged for its diligent adherence towards sustainable practices and concerted efforts in the field of corporate social responsibility (CSR), and has been conferred with the Indo-German Chamber of Commerce (IGCC) Award for ‘Outstanding Contribution towards best Sustainable Business Practices by a Large Enterprise’ for the year 2018 and the Indian Chemical Council (ICC) Award 2017 Certificate of Merit for Social Responsibility.

17 winners chosen from over 250 entries, with Nanobiotix winning both ‘CEO‘ and ‘Pharma Company of the Year’ categories

Sandoz, a Novartis division and the global leader in biosimilars, announced a global resolution of all intellectual property (IP) related litigation with AbbVie concerning the proposed Sandoz biosimilar Hyrimoz® (adalimumab) for reference medicine Humira®** (adalimumab).

Almac Diagnostic Services, a global stratified medicine company specialising in biomarker driven clinical trials, has made a significant investment in a new Illumina NovaSeq 6000 sequencer which will benefit Biopharma clients’ biomarker discovery and clinical trial projects.

Roche announced that the US FDA has approved Hemlibra® (emicizumab-kxwh) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children, ages newborn and older, with haemophilia A without factor VIII inhibitors.

Oxford Genetics, a leader in innovative synthetic biology-based technologies for biologics discovery, development and delivery, and ERS Genomics have extended their pre-existing non-exclusive, license agreement for the use of CRISPR gene editing technology.

ADC Biotechnology (ADC Bio) predicts that the next crucial phase of innovation to optimise and streamline production processes of ADCs will be designed at the clinical development stage by specialist, ADC focused service providers.

Biogen and Neurimmune announced that Biogen has exercised its option to further reduce the previously negotiated royalty rates payable on potential future sales of aducanumab, Biogen’s Phase 3 investigational treatment for early Alzheimer’s disease.

GamaMabs Pharma, a biotechnology company developing optimized therapeutic antibodies targeting the Anti-Müllerian Hormone Receptor II (AMHRII) for the treatment of cancer, announces that it has dosed the first patient in its Phase 2 clinical trial - of GM102 single agent and in combination with Trifluridine/Tipiracil (Lonsurf) - in patients with advanced or metastatic colorectal cancer (CRC).

Thrombolytic Science, LLC (TSI) today announced initiation of a Phase 2 clinical trial to confirm the efficacy and safety of its sequential dual-treatment regimen of low-dose tissue plasminogen activator (tPA) and HisproUK (TSI’s mutant prourokinase [proUK]) in patients who have experienced ischemic stroke.

CRF Health, the leading provider of patient-centered eSource technology solutions for the life sciences industry, announced that its TrialMax® Slate solution has been selected by a US biotech company for a global Phase III prostate cancer study.

Multisorb, the leading provider of oxygen and moisture management technologies, announced the inauguration of a new manufacturing facility in Hyderabad, India.

Medical Technology company IME Medical Electrospinning, developer, producer and scientific partner in the field of biomedical electrospinning processes and equipment, announced that its high-end laboratory and a brand new set of cleanrooms have become operational.

STA Pharmaceutical Co., Ltd., (WuXi STA) – a subsidiary of WuXi AppTec – and Antengene Corporation, a biopharmaceutical company, recently announced a strategic partnership for the CMC development and manufacturing of innovative oncology drugs.

CEIV Pharma (the Center of Excellence for Independent Validators in Pharmaceutical Logistics) certification is a quality assurance program for the temperature-controlled transportation of pharmaceutical products, developed by the International Air Transport Association (IATA).

Smart Skin Technologies and SCHOTT have announced plans to enter into a strategic cooperation.

Recipharm, a leading contract development and manufacturing organisation (CDMO), has released its first serialised products to Europe from its facilities in Lisbon, Portugal and Stockholm, Sweden.

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